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Completed

NCT Number: NCT05468632

A Study in North Macedonia Investigating Retrospective Data of Glucagon-like Peptide-1 (GLP-1) Participants With Type 2 Diabetes (T2D) in Real World Environment (RWE) Setting (MIRAGE)

The purpose of this study is to investigate glycaemic control and other clinical parameters in glucagon like peptide -1 (GLP-1) naive adult participants with type 2 diabetes (T2D) who initiated once weekly (OW) semaglutide in local clinical practice in North Macedonia. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion. The total duration of the study is planned to be approximately 30 weeks which is the period from OW semaglutide initiation to end of follow up.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Bitola, North Macedonia

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age above or equal to 18 years at the time of once weekly (OW) semaglutide initiation.
  • The decision to initiate treatment with commercially available OW semaglutide has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
  • Adult participants with type 2 diabetes (T2D) initiated with OW semaglutide at least 30 +- 4 weeks prior to data collection.
  • Participants should have baseline glycated haemoglobin (HbA1c) measurement and at least one HbA1c measurement after baseline. For baseline HbA1c measurement, the most recent value less than 12 weeks prior to OW semaglutide initiation will be used.

Exclusion criteria

  • Previous participation in this study.
  • Prior use of GLP-1 within last one year.
  • Participants with type-1 diabetes and gestational diabetes.

Treatment and study plan

semaglutide

Drug

Participants who initiated once weekly (OW) semaglutide in routine clinical practice in were enrolled in the study. The participants were treated according to current clinical practice, applicable local labels, and standard of care as per physicians' discretion.

Primary outcomes

  1. Change in glycated haemoglobin (HbA1c)

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as percentage (%) point.

Secondary outcomes

  1. Change in body weight

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured in kilograms (kg).

  2. Change in body weight

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as percentage (%).

  3. Change in waist circumference

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured in centimeter (cm).

  4. Change in fasting plasma glucose (FPG)

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured in millimoles per liter (mmol/l).

  5. Change in Lipid parameters (total cholesterol, low density lipoprotein cholesterol [LDLc], high density lipoprotein cholesterol [HDLc], triglycerides)

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured in millimoles per liter (mmol/L).

  6. Change in Blood Pressure (systolic and diastolic)

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured in millimiters of mercury (mmHg).

  7. Glycated haemoglobin (HbA1c) less than 7%

    Time frame: At end of follow-up (week 30 +- 4 weeks)

    Measured as Yes/No.

  8. Reduction in glycated haemoglobin (HbA1c) greater than or equal to (>=) 1%

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as Yes/No.

  9. Weight loss >= 5%

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as Yes/No.

  10. Weight loss >= 3%

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as Yes/No.

  11. HbA1c reduction >= 1% and weight loss of >=3%

    Time frame: From baseline (week 0) to end of follow-up (week 30+- 4 weeks)

    Measured as Yes/No.

  12. Having at least 1 severe hypoglycaemic episode

    Time frame: At end of follow-up (week 30 +- 4 weeks)

    Measured as Yes/No.

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Single-arm, Retrospective Study Investigating Glycaemic Control in GLP-1 Naive Participants With Type 2 Diabetes Who Initiated Once-weekly Semaglutide (OZEMPIC) in a Real World Setting in North Macedonia

Acronym: MIRAGE

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2022
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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